Clinical Comparison of QUANTA Flash dsDNA Chemiluminescent Immunoassay with Four Current Assays for the Detection of Anti-dsDNA Autoantibodies

Table 1

Characteristics of the anti-dsDNA antibody assays used in this study.

Characteristic	QUANTA Flash dsDNA	QUANTA Lite dsDNA SC	BioPlex 2200 dsDNA	ImmuLisa dsDNA	NOVA Lite dsDNA
Manufacturer	Inova Diagnostics	Inova Diagnostics	Bio-Rad	Immco Diagnostics	Inova Diagnostics
Technology	CIA	ELISA	ALBIA	ELISA	CLIFT
Assay timer	30 min	90 min	45 min	90 min	60 min
Detection	Quantitative	Quantitative	Quantitative	Semi-quantitative	Semi-quantitative
Analytical measuring range	9.8–666.9 IU/mL	12.3–1000 IU/mL	1–300 IU/mL	13.6–450 IU/mL	N/A
Cut-off value (ranges)	9.8–35 negative; 35–45 equivocal; 45 positive	12.3–30 negative; 30–75 equivocal; 75 positive	1–5 negative; 5–9 indeterminate; 9 positive	13.6–50 negative; 50–60 borderline; 60 positive	N/A
Cut-off value applied	35 IU/mL	30 IU/mL	5 IU/mL	50 IU/mL	N/A
Antigen source	Synthetic; dsDNA	Native calf thymus	Synthetic dsDNA	Purified native dsDNA	Crithidia luciliae; substrate

CIA: chemiluminescent immunoassay; ELISA: enzyme linked immunosorbent assay; ALBIA: addressable laser bead immunoassay; CLIFT: Crithidia luciliae indirect immunofluorescence test.